Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
GSO Major Duties & Responsibilities:
Internal & External Safety Expert:
Provide PV and risk management expertise to internal and external customers
Safety expert for product
Maintain knowledge of product, product environment, and recent literature
Maintain PV expertise, and understanding of international safety regulations and guidelines
Lead cross functional Safety Management Teams (SMTs)
Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
Provide strategic and proactive safety input into development plans
Support due diligence activities and pharmacovigilance agreements
Impact:
Ongoing assessment of the safety status of the product
Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
Management of product safety alerts
Ensuring the PSPV position is well articulated to and understood by its internal and external customers
Establishment of credibility of GSO function and of PSPV
Signal Detection and Assessment:
Responsible for signal detection and analysis
Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
Identify and implement proactive safety analysis strategies to further define the safety profile.
Lead aggregate safety data review activities and coordinate safety surveillance activities
Impact:
Signal detection and analysis
Development of safety action plans and implementation, as appropriate
Enable effective development of product safety
Enable appropriate risk management
Enable up-to-date risk communication (e.g. labeling)
Co-lead benefit-risk assessment with other relevant functions
Develop risk management strategies and plans and monitor effectiveness
Collaborate with Center of Excellence for Risk Management and Safety Epidemiology
Impact:
Optimization of the product benefit risk profile
Development of REMS, Risk Management and Development Risk Management plans
Identification and implementation of risk mitigation or other corrective actions as necessary
Regulatory compliance
Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
Submission Activities:
Represent safety position in cross functional submission teams
Ensure generation, consistency, and quality of safety sections in submission documents
Write responses or contributions to health authorities' questions
Support preparation and conduct of Advisory Committee meetings
Impact:
Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:
For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports
For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports
Serve as the medical safety expert to the PSPV Periodic Reports group for assigned projects and products.
About You
Qualifications
Knowledge and Skills
Excellent clinical judgment
Capability to synthesize and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Demonstrates leadership within cross-functional team environment
Excellent teamwork and interpersonal skills are required
Fluent in English (written and spoken).
Formal Education And Experience Required
M.D. Degree or equivalent.
For MD, Board Certified/Board eligible, or equivalent, is preferred
For M.D., minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
